Milnacipran (Savella) in Irritable Bowel Syndrome (IBS)
Summary
Purpose: The investigators are proposing to examine the use of Savella® (Milnacipran) for treating irritable bowel syndrome (IBS) in women. Participants: Eligible participants will meet the Rome III diagnostic criteria for IBS. Procedures: This study will observe patients treated with Savella® as well as patients treated with a placebo (pill with no active drug). The investigators will monitor and compare several patient and symptom related outcomes, as well as evaluate health related quality of life, psychological distress and related psychosocial measures to determine if the addition of Savella® improves clinical pain response as well as secondary outcomes including quality of life.
Timeline
- Start
- 2012-04
- Primary completion
- 2013-02
- Completion
- 2013-02
Outcome
Outcome not reported
Stopped (Enrollment): “Due to recruitment difficulties the study is terminated.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Milnacipran | Other / unclassified | 50 mg | Oral |
| Comparator | Milnacipran | Other / unclassified | 100 mg | Oral |